Validation Engineer - Fremont Area

Validation Engineer | Fremont, MI

Salary Range: $79,000 - $119,000 depending on experience

Are you a skilled professional with a passion for excelling in validation engineer? The Pivot Group is dedicated to building meaningful connections in the manufacturing community. We are collaborating with companies in Fremont seeking experienced Validation Engineers.

The Opportunity

We are collaborating with manufacturing firms in Fremont that are seeking skilled Validation Engineers. These organizations are dedicated to maintaining high standards and are looking for professionals who can contribute effectively. By joining our network, you position yourself for opportunities aligned with your career goals.

Key Responsibilities

• Develop and execute validation protocols (IQ, OQ, PQ) for manufacturing equipment and processes.
• Document all validation activities, including deviations, change controls, and final reports.
• Ensure compliance with relevant regulatory requirements (e.g., FDA, GAMP) and internal quality standards.
• Troubleshoot and resolve validation-related issues and discrepancies.
• Support the qualification and validation of new equipment and process changes.
• Participate in risk assessments related to manufacturing processes and equipment.
• Maintain and update validation documentation and records.
• Collaborate with cross-functional teams (e.g., Engineering, Manufacturing, Quality Assurance) to achieve validation objectives.

Recommended Qualifications

• Bachelor's degree in Engineering (e.g., Mechanical, Electrical, Chemical) or a related scientific field.
• Experience with validation principles and methodologies (IQ, OQ, PQ).
• Familiarity with Good Manufacturing Practices (GMP) and regulatory requirements (e.g., FDA, ISO).
• Proficiency in developing, executing, and documenting validation protocols and reports.
• Experience with process automation and control systems.
• Strong analytical and problem-solving skills.

Bonus Qualifications

• - Experience with automated testing frameworks (e.g., Selenium, UFT).
• - Familiarity with Lean Manufacturing principles and Six Sigma methodologies.
• - Knowledge of cGMP (current Good Manufacturing Practices) and FDA regulations.
• - Proficiency in data analysis and statistical process control (SPC).
• - Experience with scripting languages (e.g., Python, PowerShell) for test automation.

Job Titles That Should Apply

Validation Engineer, Quality Engineer, QA Engineer, Quality Assurance Engineer, Test Engineer, Software Validation Engineer, Hardware Validation Engineer, Process Validation Engineer, Systems Validation Engineer, Product Validation Engineer, Compliance Engineer, Regulatory Affairs Engineer, Verification Engineer, Test Automation Engineer, Validation Specialist, Quality Control Engineer

Why Pivot Group

The Pivot Group was founded by manufacturing professionals who've been on both sides of the hiring process. Our clients are strategic—they partner with us because they want real insight into their roles and the people filling them, not a stack of resumes. We focus on match-driven placements built around what actually matters: Commute, Compensation, Culture, and Career trajectory.

If you're ready to take the next step in your career and connect with a firm that values fit over speed, we invite you to reach out. The Pivot Group offers resources to support your search—market insights, resume feedback, and interview preparation. As our partnerships grow, we'll reach out with opportunities aligned with your goals. Thank you for considering this approach to career advancement.